Business
Denali Therapeutics Reports Full Year 2019 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (\"BBB\") for neurodegenerative diseases, today reported financial results for the fourth quarter and full year ended December 31, 2019, and provided business highlights.\n “2019 was an extraordinary year for Denali with significant progress across our portfolio in programs targeting Alzheimer’s, ALS and Hunter syndrome, as well as completing our first patient trial for a LRRK2 inhibitor in Parkinson’s disease,” said Ryan Watts, Ph.D., CEO. \"We look forward to building on this momentum in 2020 with key milestones expected for multiple programs, including advancing our LRRK2 program into late stage clinical testing, and establishing clinical biomarker proof-of-concept with our first large molecule program, ETV:IDS (DNL310) in Hunter syndrome, enabled by our blood-brain barrier delivery Transport Vehicle platform.” Recent Business Highlights Biomarker proof of concept for LRRK2 inhibitor program (DNL201 and DNL151) - In January 2020, Denali presented positive results from a Phase 1b study with DNL201 in patients with Parkinson’s disease and from a Phase 1 study with DNL151 in healthy volunteers. Both clinical trials showed dose-dependent target engagement, improvement in biomarkers of lysosomal function and demonstrated safety profiles supporting progression to further development in upcoming Phase 2/3 studies. First-in-human dosing of EIF2B activator program (DNL343) - In February 2020, Denali commenced dosing of its small molecule activator of EIF2B, DNL343, in healthy volunteers. DNL343 is a brain penetrant small molecule EIF2B activator designed to resolve cellular integrated stress response and restore protein translation and RNA metabolism in ALS, Frontotemporal Dementia and other neurodegenerative diseases. IND accepted for DNL310 for Hunter syndrome - In January 2020, the IND for DNL310 was accepted and Denali plans to initiate a Phase 1/2 study for DNL310 in Hunter syndrome patients in the first half of 2020. DNL310 is an intravenously administered recombinant form of the iduronate 2-sulfatase (“IDS”) enzyme engineered to cross the BBB using Denali’s proprietary Transport Vehicle (“TV”) technology....